DONEPEZIL HYDROCHLORIDE - donepezil hydrochloride tablet, film coated 
Zydus Lifesciences Limited

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DONEPEZIL HYDROCHLORIDE TABLETS


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1320-1 in bottle of 100 tablets

Donepezil Hydrochloride Tablets, 23 mg

Rx only

100 tablets

donepezilhacltabs-image05
DONEPEZIL HYDROCHLORIDE 
donepezil hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1320
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P) DONEPEZIL HYDROCHLORIDE23 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorRED (red-brown) Scoreno score
ShapeROUND (round) Size8mm
FlavorImprint Code 521
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1320-330 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
2NDC:70771-1320-990 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
3NDC:70771-1320-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
4NDC:70771-1320-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
5NDC:70771-1320-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2018
6NDC:70771-1320-410 in 1 CARTON03/07/2018
6NDC:70771-1320-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20316203/07/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1320) , MANUFACTURE(70771-1320)

Revised: 10/2022
Document Id: 4fadc3c5-6ef7-4a62-9444-0b66ce385a7c
Set id: 4a9af634-1406-422c-b743-75272601fe6b
Version: 4
Effective Time: 20221013
 
Zydus Lifesciences Limited